The USPTO has confirmed that in light of the decision of the Supreme Court of the United States in Association for Molecular Pathology v. Myriad Genetics, Inc., 569 U.S. _, 133 S. Ct. 2107, 2116, 106 USPQ2d 1972 (2013)(Myriadnatural products are not patentable unless they are significantly different to the product as it occurs in nature.

As discussed here, the Myriad case concerned whether isolated, but naturally occurring DNA sequences are patentable. The Supreme Court held that because isolated DNA sequences are not significantly different from the sequences as they exist in nature, they do not relate to patentable subject matter.

Unlike some of the lower courts, the Supreme Court came to their decision on the basis that DNA was special or different from other naturally occurring compounds because of its information carrying properties. In the absence of such a distinction, the USPTO has decided that the decision applies to all natural products.

One of the oldest methods of drug development relates to the isolation of pharmaceutically active compounds from nature. In fact some of the world’s most famous drugs have been discovered this way. Penicillin was isolated from fungi, taxol was originally isolated from the Pacific Yew tree, while salicylic acid (the active metabolite of aspirin) was originally isolated from willow bark. As a result of the USPTO’s interpretation of Myriad, it would appear that the ability to patent such compounds in the United States has been lost.

The Position in Australia and New Zealand

The position taken by the USPTO can be directly contrasted to the position in Australia and New Zealand (discussed here) where, isolated DNA sequences, along with other isolated natural products remain patentable.

USPTO Guidelines

The USPTO has issued a document entitled Guidance For Determining Subject Matter Eligibility Of Claims Reciting Or Involving Laws of Nature, Natural Phenomena, & Natural Products available here. The document sets out how USPTO examiner’s should determine the patentability of claims involving laws of nature, natural phenomena and natural products in light of the decisions of the Supreme Court of the United States inAssociation for Molecular Pathology v. Myriad Genetics, Inc and another recent Supreme Court decision in Mayo Collaborative Services v. Prometheus Laboratories, Inc., 566 U.S. _, 132 S. Ct. 1289, 101 USPQ2d 1961 (2012).

The guidelines set out a three step test for determining whether such a claim relates to patentable subject matter:

Question 1: Is the claimed invention directed to one of the four statutory patent-eligible subject matter categories: process, machine, manufacture, or composition of matter?

This question is based on the provisions of the US statute and so does not change the position. If the answer to this question is yes, the examiner will proceed to question 2. If the answer is no, then the claim does not relate to patent-eligible subject matter and it is not necessary to proceed to questions 2 and 3.

Question 2: Does the claim recite or involve one or more judicial exceptions?

Particular judicial exceptions referred to in the guidelines include abstract ideas, laws of nature/natural principles, natural products and natural phenomena. If the answer to this question is yes then the examiner will proceed to question 3. If there is any doubt over the answer to this question then the examiner will proceed to question 3. If the answer is no then the claims relate to patent-eligible subject matter.

In terms of natural products, the guidelines state that the following will always be subject to the third question:

“...chemicals derived from natural sources (e.g., antibiotics, fats, oils, petroleum derivatives, resins, toxins, etc.); foods (e.g., fruits, grains, meats and vegetables); metals and metallic compounds that exist in nature; minerals; natural materials (e.g., rocks, sands, soils); nucleic acids; organisms (e.g., bacteria, plants and multicellular animals); proteins and peptides; and other substances found in or derived from nature.”

Question 3: Does the claim as a whole recite something significantly different than the judicial exception(s)?

The guidelines clearly anticipate that Question 3 will be the most difficult for examiner’s to assess and sets out a multi-factorial analysis to determine if the claimed subject matter is ‘significantly different’.

Factors in favour of patentability include:

“a) Claim is a product claim reciting something that initially appears to be a natural product, but after analysis is determined to be non-naturally occurring and markedly different in structure from naturally occurring products.

b) Claim recites elements/steps in addition to the judicial exception(s) that impose meaningful limits on claim scope, i.e., the elements/steps narrow the scope of the claim so that others are not substantially foreclosed from using the judicial exception(s).

c) Claim recites elements/steps in addition to the judicial exception(s) that relate to the judicial exception in a significant way, i.e., the elements/steps are more than nominally, insignificantly, or tangentially related to the judicial exception(s).

d) Claim recites elements/steps in addition to the judicial exception(s) that do more than describe the judicial exception(s) with general instructions to apply or use the judicial exception(s).

e) Claim recites elements/steps in addition to the judicial exception(s) that include a particular machine or transformation of a particular article, where the particular machine/transformation implements one or more judicial exception(s) or integrates the judicial exception(s) into a particular practical application..

f) Claim recites one or more elements/steps in addition to the judicial exception(s) that add a feature that is more than well-understood, purely conventional or routine in the relevant field.”

Factors which weigh against patentability include:

“g) Claim is a product claim reciting something that appears to be a natural product that is not markedly different in structure from naturally occurring products.

h) Claim recites elements/steps in addition to the judicial exception(s) at a high level of generality such that substantially all practical applications of the judicial exception(s) are covered.

i) Claim recites elements/steps in addition to the judicial exception(s) that must be used/taken by others to apply the judicial exception(s).

j) Claim is a product claim reciting something that appears to be a natural product that is not markedly different in structure from naturally occurring products.

k) Claim recites elements/steps in addition to the judicial exception(s) at a high level of generality such that substantially all practical applications of the judicial exception(s) are covered.

l) Claim recites elements/steps in addition to the judicial exception(s) that must be used/taken by others to apply the judicial exception(s).”

Tellingly, the Guidelines also provide several examples, of which example B makes it very clear that a compound isolated from nature is not patent-eligible subject matter.

There is some argument that the USPTO has extended the principles in Myriad beyond what the Supreme Court intended, and it is possible that future decision will limit Myriadto genetic material. However in the meantime it would seem that applications directed to products isolated from nature will be rejected.